Hearing Lab Technology, LLCApril 20, 2023

FDA 483 - Hearing Lab Technology, LLC - April 20, 2023

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Record Details

An FDA inspection of Hearing Lab Technology, LLC in Bristol, PA, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to establish procedures for finished device acceptance, specifically for wireless functionality testing of their in-the-ear wireless hearing aids. Additionally, device history records lacked proper documentation and signatures for manufacturing and quality control steps.

Company: Hearing Lab Technology, LLC
Inspection Date: April 20, 2023
Product Type: Device
Office: Philadelphia District Office
Person: Edward D. McDonald (Investigations)

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ID · 89079eba-3b02-4b78-a264-5100f6044f59